Hypospadias Clinical Trial
Official title:
The Effect of Amniotic Membranes on Complex Genitourinary Reconstruction Outcomes in Pediatric and Adult Populations
NCT number | NCT03685955 |
Other study ID # | IRB00168089 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | March 2020 |
Est. completion date | March 2021 |
Verified date | August 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Urinary fistulas are unfortunately one of the most common post operative complications in hypospadias repairs and bladder neck transections on pediatric and adult populations, an estimated 20%, resulting in multiple repeat operations with prolonged hospitalization. The negative sequelae of these fistulas have significant financial and psychosocial impact and the aim of this study is to evaluate if the fresh frozen preserved amniotic membrane tissue studied, which have live cells and intact naturally occurring growth hormones and peptides that augment healing that have been shown in early studies to be effective facilitating previous failed fistula repairs and leg ulcer healing, respectively, will help reduce the incidence of urinary fistulas in subject populations.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 99 Years |
Eligibility |
Inclusion Criteria: - 6mo - 99 years old - Undergoing surgical procedure with risk of or known urinary fistula Exclusion Criteria: - Failed prior repair with amniotic membranes - Sensitivity to cryopreservation fluids or disinfecting solutions. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Johns Hopkins University |
Batsali AK, Kastrinaki MC, Papadaki HA, Pontikoglou C. Mesenchymal stem cells derived from Wharton's Jelly of the umbilical cord: biological properties and emerging clinical applications. Curr Stem Cell Res Ther. 2013 Mar;8(2):144-55. Review. — View Citation
Cooke M, Tan EK, Mandrycky C, He H, O'Connell J, Tseng SC. Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorion tissue. J Wound Care. 2014 Oct;23(10):465-74, 476. doi: 10.12968/jowc.2014.23.10.465. — View Citation
Duan-Arnold Y, Gyurdieva A, Johnson A, Uveges TE, Jacobstein DA, Danilkovitch A. Retention of Endogenous Viable Cells Enhances the Anti-Inflammatory Activity of Cryopreserved Amnion. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):523-533. — View Citation
Frykberg RG, Gibbons GW, Walters JL, Wukich DK, Milstein FC. A prospective, multicentre, open-label, single-arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane. Int Wound J. 2017 Jun;14(3):569-577. doi: 10.1111/iwj.12649. Epub 2016 Aug 3. — View Citation
Johnson EL, Tassis EK, Michael GM, Whittinghill SG. Viable placental allograft as a biological dressing in the clinical management of full-thickness thermal occupational burns: Two case reports. Medicine (Baltimore). 2017 Dec;96(49):e9045. doi: 10.1097/MD.0000000000009045. — View Citation
Lavery LA, Fulmer J, Shebetka KA, Regulski M, Vayser D, Fried D, Kashefsky H, Owings TM, Nadarajah J; Grafix Diabetic Foot Ulcer Study Group. The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre — View Citation
Suzuki K, Michael G, Tamire Y. Viable intact cryopreserved human placental membrane for a non-surgical approach to closure in complex wounds. J Wound Care. 2016 Oct 1;25(Sup10):S25-S31. doi: 10.12968/jowc.2016.25.Sup10.S25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Failure rate of complex genitourinary reconstruction after incorporation of placental membranes into repair. | We will evaluate patients with complex genitourinary wounds who have undergone surgical repair using preserved placental membranes, Grafix or Stravix. They will be evaluated in the standard post operative fashion to evaluate for failure of surgical repair of complex genitourinary reconstruction which will be defined by stricture recurrence, wound dehiscence, or recurrence of fistula. | 2 years |
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